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Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters

Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04099225
Enrollment
104
Registered
2019-09-23
Start date
2015-08-31
Completion date
2019-05-31
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects, Non-smokers, Smokers

Brief summary

Multiple breath washout (MBW) using Sulphur hexafluoride (SF6) has the potential to reveal ventilation heterogeneity in obstructive lung disease which is frequent in patients with small airway disease. However, it is missed by commonly used tests with reference data being scarce and mostly restricted to younger collectives. We aimed to evaluate the influence of anthropometric parameters on SF6-MBW reference values in pulmonary healthy adults.

Interventions

DIAGNOSTIC_TESTMultiple breath washout (MBW) testing

Lung clearance index (LCI), acinar (Sacin) and conductive (Scond) ventilation heterogeneity were derived from triplicate SF6-MBW measurements. Global ventilation heterogeneity was calculated for the 2.5% (LCI2.5) and 5% (LCI5) stopping points.

Sponsors

Universitätsmedizin Mannheim
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

non-smoker * no history of pulmonary disease * absence of dyspnoea, cough, thoracic pain * no self-reported smoking history * normal lung function testing * normal shape of flow-volume curve * normal shape of flow-pressure curve * FEV1/FVC \>70% (forced expiratory volume in 1 second / forced vital capacity) * TLC \> 80% of predicted (total lung capacity) * TLCO/VA \> 80% of predicted (transfer factor corrected for ventilated alveolar volume) * R5 \< 150% of predicted (resistance at 5Hz, impulse oscillometry) smoker \- as above, but with self-reported smoking history \>10 pack years

Exclusion criteria

* unwilling or unable to give informed consent * history of any respiratory disease

Design outcomes

Primary

MeasureTime frameDescription
Lung clearance index (LCI) derived from multiple breath washout testing (MBW)30 minutesglobal ventilation heterogeneity

Secondary

MeasureTime frameDescription
Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW)30 minuteslocal ventilation heterogeneity
Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW)30 minuteslocal ventilation heterogeneity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026